OBJECTIVE  To observe the clinical efficacy of Qianyang Yuyin Granules in the treatment of hypertensive patients with cognitive impairment and the effect on their leukoencephalopathy volume.

  METHODS  The patients were randomly divided into 64 cases in the treatment group, 33 cases in the control group, and 34 cases in the donepezil group by randomized controlled, multicenter enrollment. In the control group, the patients were treated with conventional western medicine, while in the treatment group and donepezil group, the patients were separately treated with Qianyang Yuyin Granules and donepezil based on the therapies in the control group. The course of the treatment was 6 months.The changes of blood pressure, leukoencephalopathy volume, Mini-Mental State Examination (MMSE), Vascular Dementia Assessment Scale (VaDAS-cog), as well as traditional Chinese medicine (TCM) syndrome score were compared before and after treatment in the three groups. Besides, the changes of safety indexes such as blood routine examination, liver and kidney function were also observed.

  RESULTS  After treatment, blood pressure was lowered significantly in all three groups (P < 0.01), with no significant differences between each groups(P>0.05). The TCM syndrome score were reduced in all three groups (P < 0.01), while the treatment group showed better results than the control group and the donepezil group did (P < 0.01). The leukoencephalopathy volumes were increased significantly in all three groups (P < 0.01), but the increase of leukoencephalopathy volume in the treatment group was less than that in the control group and the donepezil group (P < 0.05). MMSE scores were increased significantly in the treatment group (P < 0.01), whose results were better than those in the control group and the donepezil group (P < 0.01). VaDAS-cog scores were decreased significantly in the treatment group (P < 0.01), whose results were also better than those in the control group (P < 0.01). In addition, no significant adverse reactions were observed in any of the three groups during the treatment period.

  CONCLUSION  The Qianyang Yuyin Granules can notably improve the cognitive function of hypertensive patients, and can evidently slow their progression of leukoencephalopathy with safety.